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ISO 14971 Fundamentals: Characteristics related to safety
Best practices for identifying safety characteristics and connecting them to design controls.
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Naveen Agarwal, Ph.D.
5
Medical Device News Update - March 2025
FDA approvals, warning letters and Class I recalls issued during March 2025
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Naveen Agarwal, Ph.D.
Webinar 10: Tips for medical device software risk analysis
An overview of key challenges and tips for analyzing the risks of medical device software failures.
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Naveen Agarwal, Ph.D.
2
48:31
LTR 102: Collaboration that drives innovation, not delays
Deep insights from a conversation with Ahmet Tezel.
34:53
LTR 82: Tips for Regulatory Success with AI Devices in Radiology
Deep insights from a conversation with Dr. Jay Vaishnav.
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Naveen Agarwal, Ph.D.
28:54
Medical Device Recalls - Part 1: High Level Overview
A high level overview of 283 Class I recalls of medical devices in the last 3 years.
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Naveen Agarwal, Ph.D.
2
Webinar 7: How to create a master harms list using standard codes
A step by step method to help you create a master harms list using FDA, IMDRF or MedDRA codes.
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Naveen Agarwal, Ph.D.
1
56:50
Case study: Neither a SaMD, nor a SiMD; maybe a SaMDA?
A mobile medical app crashing can cause a life-threatening emergency and send you to the hospital. It seems to have fallen through a crack in the…
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Naveen Agarwal, Ph.D.
1
3 critical gaps to address in lifecycle management of AI in MedTech
AI/ML applications in MedTech are rising exponentially. However, key gaps remain in governance and lifecycle management of AI systems to support rapid…
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Naveen Agarwal, Ph.D.
Medical Device News Update - July 2024
FDA approvals, warning letters and Class I recalls issued during July 2024
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Naveen Agarwal, Ph.D.
Tuning into the Bottom Line: Why QA/RA Professionals Should Listen to Earnings Calls
Learn to speak the language of business by listening to how senior executives speak.
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Naveen Agarwal, Ph.D.
2
Medical Device News Update - October 2024
FDA approvals, warning letters and Class I recalls issued during October 2024
 • 
Naveen Agarwal, Ph.D.
© 2025 Naveen Agarwal, Ph.D.
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